Panel 3 cristina possas


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Panel 3 cristina possas

  1. 1. Conference FDUSP UAEM The Right to Health: the Role of Universities in the access to medicines São Paulo, August 17, 2010 Licensing for Access: Compulsory and Humanitarian Licenses Cristina de A. Possas Research and Technological Development Unit National STD, AIDS and VH Program MOH - Brazil Ministério da Saúde
  2. 2. I. The dramatic global scenario • Data (WHO/UNAIDS, 2007) indicate there are 33 million HIV infected people in the world (70% are in Africa). Every year 2.5 million people get infected and 2 million die of AIDS. • Prospects for the future – The situation tends to aggravate with the economic crisis. It is estimated that with the aggravation of this scenario, by 2025 around 67 million people will have died with AIDS in Africa since the beginning of the epidemics (UNAIDS AIDS Africa Project, 2004)‫‏‬ Ministério da Saúde
  3. 3. • Challenge: access to ARV therapy A human rights issue Ministério da Saúde
  4. 4. III. Access: progress in drug development but reduced impact on public health • Contrasting with rapid innovation in ARV development, 75% of HIV/AIDS patients in the world still without access to continued treatment. • Despite several international initiatives to improve access, this situation tends to aggravate with the recent economic crisis. Ministério da Saúde
  5. 5. IV. Price Trends • TRIPS post-2005 scenario – compliance to TRIPS with increased patent protection, higher prices of ARV drugs and obstacles to access • Bilateral FTA agreements reducing TRIPS flexibities • Spiraling prices of second and third generations of new patented ARV drugs Ministério da Saúde
  6. 6. Compulsory and humanitarian licenses • Increased patent protection limits the export of active principles and production of generics by India and China, the main exporters to Brazil. • Developing countries are becoming increasingly dependant on humanitarian and compulsory licenseseto reduce the prices of ARV drugs. Ministério da Saúde
  7. 7. Another global constraint impacting on prices: scarcity of API • API producers remain basically the same, but international demand is increasing very fast • Developing countries: Urgent need for a strategic supply and for building national production capacity for API Ministério da Saúde
  8. 8. Brazil: success of universal access • 70% decline in mortality and 80% in hospitalizations from 1996 to 2002 • Prevalence of 0,6% (2006)‫‏‬ • Low levels of resistance to ARV drugs when compared to other countries (Brindeiro et al.)‫‏‬ • 80% of patients in treatment with undetectable viral load (SISCEL 2009). • The role of ARV in prevention Ministério da Saúde
  9. 9. Brazilian expenditure with ARV • The annual expenditure by the government with ARV is US$ 400 million for 195.000 patients in treatment– 62% of total government expenditure with the epidemics (2009). • Increased expenditure with 3rd line drugs – from 2005 to 2008 increased 352% - from US$ 20,4 million to US$ 71,6 million. Participation in total expenditure increased from 4,1% to 15,7%. Protected by patents and no generic competition. Ministério da Saúde
  10. 10. Brazil 2005: attempt for compulsory licenses 4 of the 17 ARV drugs distributed by the Ministry of Health:70% of expenditure • Efavirenz (Merck, Sharp & Dome) –US$ 1,575/capsule – average cost of treatament/patient/year: US$ 574.80 • Nelfinavir (Roche) –US$ 0.468/capsule – average cost of treatament/patient/year : :US$ 1,537.00 • Lopinavir/ritonavir (Abbott) –US$ 1.30/ capsule – average cost of treatament/patient/year: US$ 2,847.00 • Tenofovir (Gilead Sci.) -US$ 7.68/ capsule – average cost of treatament/patient/year: US$ 2,803.00 Ministério da Saúde
  11. 11. Economy of public ressources • Economy of US$ 154,8 mi after compulsory license of Efavirenz in 2007 (drastic reduction of the price of the capsule from US$ 1,59 to US$ 0,45). • After the oppostion to Tenofovir´s patent in 2009 the economy was US$ 23,7 mi • Price negotiations from 2003 to 2010: economy was 154,8 mi Ministério da Saúde
  12. 12. Political impasse: compulsory licensing is complex • It is a flexility of TRIPS, but an exception instrument (public interest, emergency), cannot be a routine for all ARV drugs. • In many developing countries, local governments are often paralised by economic and political pressures, legal uncertainties , in the compulsory licensing process • Brazil: several attempts of compulsory licensing of ARV drugs before Efavirenz Ministério da Saúde
  13. 13. The issue of sustainability of universal access to ARV in Brazil • Concern: in spite of significant economy of public ressources with compulsory license of Efavirenz in 2007 and more recently the refusal of Tenefovir´s patent, the issue of sustainability remains. • Government expenditure with third line ARV drugs protected by patents, consummed by only 3% of patients, is increasing exponentially and is now equivalent to expenditure with first line drugs consummed by 50% of patients. Ministério da Saúde
  14. 14. 1.The need to conceive and implement alternative incentives to innovation • The main argument of multinational pharmaceutical enterprises is that more flexible IPR and compulsory licenses will undermine their long term investments in R & D and innovation • R & D Funds: divided between direct payment to patent owner and investiment in R & D Fund (Love, 2005). From a royalty of 3.5 per cent – 2 per cent for patent owner – 1.5 per cent for R & D Fund – Patent owner would have participation in the Fund • Patent pools for licensing – collaborative strategy for collective assessment of property rights – needs the involvement of industry • A new system to pay for innovation – market for products separated from market for innovations: health products would be available to the consumer at generic prices, while innovators would benefit from a separated system (Medical Innovation Prize Fund)‫‏‬ Ministério da Saúde
  15. 15. 4. R & D Networks: South to South Cooperations • Friends of Development - WIPO • Network for Technological Cooperation set by Brazil with several developing countries in XV AIDS Conference in Bangkok 2004 • Network for IPR Research - Portuguese Speaking Countries • IBSA – India, Brazil and South Africa – HIV Vaccine and other areas of health research Ministério da Saúde
  16. 16. International trends • On one hand, pressures from developing countries for a more flexible IPR regime • On the other hand, international movements led by developed nations towards more strict IPR regimes: bilateral commercial agreements signed by U.S. with developing countries (TRIPS Plus) such as Singapore, Morocco, Jordan • Question: Which of these trends will prevail? Ministério da Saúde
  17. 17. The main issues • How to conceive national legal systems tailored to local needs: IPR and evolving industrial structure • Maximum use of permitted flexibilities such as compulsory and humanitarian licenses, freedom to operate and research exemptions • Innovation and enhanced technical capacity within research institutions and universities. Ministério da Saúde
  18. 18. The impact of IP regimes • The detrimental impact of dysfunctional IP regimes is both economic and social, as they ultimately affect both the pace of innovation and the public benefits of research. • Free circulation of knowledge is crucial to confront pandemics such as HIV/AIDS. Ministério da Saúde
  19. 19. The role of the university: topics for a research agenda • Alternative incentives to innovation: new regulatory strategies and new business models • Clinical Trials: constraints from data exclusivity related to IP • HIV Vaccines and IP – how to prevent future problems of prices and access (HPV and other) • Harmonization and national specificities • R & D Networks linking developing countries • IP, Ethics and Human Rights: the role of civil society organizations Ministério da Saúde
  20. 20. Final considerations • Urgent need to review international IP legislation and policies and to conceive more flexible IPR regime and alternative incentives to innovation. • Need for stronger political pressures and new networking initiatives connecting developing countries • Research Agenda in Universities and Institutes is key to support local decision making Ministério da Saúde